Company ยท US
Gn Otometrics
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2016. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2016 | K161707 | Madsen Zodiac Gn Otometrics, DK | ETY |
| Nov 16, 2015 | K151504 | ICS Impulse Gn Otometrics, DK | GWN |
| Feb 27, 2014 | K132957 | MADSEN ACCUSCREEN TYPE 1077 Gn Otometrics | GWJ |
| Feb 1, 2013 | K122550 | ICS IMPULSE Gn Otometrics | GWN |
| Oct 23, 2012 | K122028 | AURICAL HIT Gn Otometrics | ETW |
| Sep 27, 2012 | K122067 | TYPE 1077 ACCUSCREEN Gn Otometrics, DK | GWJ |
| Sep 3, 2009 | K092373 | ICS CHARTR EP 200 Gn Otometrics | GWJ |
| Jul 14, 2008 | K081234 | GN OTOMETRICS INSERT EARPHONES Gn Otometrics | EWO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2019 | GN Otometrics Gold Cup Leadwire and Snap Leadwire with the following component descriptions:
1. 24" Snap Leadwire, Blue;
2. 40" Snap Leadwire, Blue;
3. 24" Snap Leadwire, Red;
4. 40" Snap Leadwire, Red; Open, Classified |
DSA | K080112 |
| May 28, 2019 | GN Otometrics The ICS CHARTR EP 200 Terminated |
GWJ | K083399 |